Impact of the PET in the Diagnosis Strategy of FUO or Inflammatory Syndrome in Immunocompetent Patients FUO-TEP

NCT01200771 — Not applicable, Completed, 116 participants, University Hospital, Limoges

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Impact of the PET-scan in the Diagnosis Strategy of Fever Unknown Origin or Inflammatory Syndrome in Immunocompetent Patients

RegistryNCT01200771, acronym FUO-TEP
StatusCompleted
PhaseNot applicable
Study typeInterventional; na, single group, masking: none, diagnostic
Enrollment116 (Actual)
SponsorUniversity Hospital, Limoges (Other)
ConditionsFever
InterventionsTEP (Procedure)
Datesstart 2008-05-01, primary completion 2012-05-01, completion 2014-02-01, first posted 2010-09-14, last updated 2025-07-20
Locations19 sites in France

Related Papers Related Patents Related Grants Related Experts
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-Summary

Fever of unknown origin (FUO) and chronic inflammatory syndrome could be seen in many affections. The diagnostic process is still a challenge and could not be specified yet after several clinical studies performed by trained teams using two levels diagnostic procedures. For this reason, the diagnosis involves many additional and expensive tests such as computed tomography (CT scan), scintigraphic imaging, endoscopy, biopsy. There is no evidence-based recommendation for the diagnostic work-up of FUO or chronic inflammatory syndrome. Positron emission tomography with 2-\[18F\] fluoro-2-deoxy-D-glucose combined with CT scan (FDG-PET/CT) is widely used in malignant diseases and seems to be promising for the diagnosis of inflammatory disorders. Its role has not been yet clearly defined in the investigation of FUO and chronic inflammatory syndrome.

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+Detailed description

All patients with FUO and chronic inflammatory syndrome will undergo FDG-PET/CT and conventional morphologic imaging modalities. Results of these two diagnostic procedures in identifying diagnostic clues will be compared.

We assume FDG-PET/CT could be safer and more helpful to reach early final diagnosis in patients with FUO and chronic inflammatory syndrome than conventional morphologic imaging modalities

+Arms and interventions

  • TEP (Procedure): Intravenous injection of glucose labeled Fluor 18. The patient remains fasted at least 6 hours before the start of the examination. The review lasted 1 hour, during wich the patient should not move.

+Outcome measures

Primary outcomes

  • To assess the contribution of FDG-PET/CT in the early diagnostic work-up of patients with FUO or chronic inflammatory syndrome [3 month]

Secondary outcomes

  • To establish the role of FGD PET in reaching final diagnosis compared to conventional morphologic imaging modalities including computer tomography and gallium-67 citrate scintigraphy. [3 months]
  • To evaluate sensitivity and specificity of this diagnostic procedure [3 months]
  • To analyse the cost effectiveness of this diagnostic approach [3 months]

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* Patient with FUO criteria:

Fever since 3 weeks, Temperature > 38.3°C, No diagnostic after 3 days of hospitalization.

* Patient with periodic fever criteria:

Fever with criteria like FUO, Fever-free intervals, and apparent remission of the underlying disease, At least 3 febrile episodes.

* Inflammatory syndrome without any clinical sign, Important inflammatory syndrome: Erythrocyte sedimentation rate ≥ 50 at the first hour, and elevation of at least one another inflammatory parameter (haptoglobin, orosomucoïd, fibrinogen or C-reactive protein), Evolution since more than 3 weeks, No diagnostic orientation after clinical examination and history-taking, No diagnostic clue after 3 days of hospitalisation.
* Oral informed consent obtained.

Exclusion Criteria:

* Demented patient or unable to receive information on the protocol and to give informed consent.
* Pregnant women, or without contraception.
* Contraindication to iodine examination, gallium scintigraphy or 18FDG TEP-scan.
* Immunodeficient patient.
* Know HIV infection, neutropenic patient and nosocomial fever.

+Locations (19)

FacilityCityCountryStatus
Médecine Interne - CHUAmiens, FranceFrance
Médecine Nucléaire - CHUAmiens, FranceFrance
Médecine Interne - CHULille, FranceFrance
Médecine Nucléaire et Imagerie Fonctionnelle - CHULille, FranceFrance
Médecine Interne - CHULimoges, FranceFrance
Médecine Nucléaire - CHULimoges, FranceFrance
Médecine Interne - AP-HP - Hôpital Hôtel DieuParis, FranceFrance
Médecine Nucléaire - AP-HP - Hôpital Hôtel DieuParis, FranceFrance
Médecine Interne - AP-HP - La Pitié SalpétrièreParis, FranceFrance
Médecine Nucléaire - AP-HP - La Pitié SalpétrièreParis, FranceFrance
Médecine Interne - AP-HP - Hôpital CochinParis, FranceFrance
Médecine Interne - AP-HP - Hôpital BichatParis, FranceFrance
Médecine Nucléaire - AP-HP - Hôpital BichatParis, FranceFrance
Service des Isotopes - CRLCC Centre Eugène MarquisRennes, FranceFrance
Département de Médecine pour adulte - CHURennes, FranceFrance
Médecine Interne - CHRodez, FranceFrance
Médecine Nucléaire - CHRodez, FranceFrance
Médecine Interne - CHUToulouse, FranceFrance
Médecine Nucléaire - CHUToulouse, FranceFrance

+Publications

  • Results publication: Ly KH, Costedoat-Chalumeau N, Liozon E, Dumonteil S, Ducroix JP, Sailler L, Lidove O, Bienvenu B, Decaux O, Hatron PY, Smail A, Astudillo L, Morel N, Boutemy J, Perlat A, Denes E, Lambert M, Papo T, Cypierre A, Vidal E, Preux PM, Monteil J, Fauchais AL. Diagnostic Value of 18F-FDG PET/CT vs. Chest-Abdomen-Pelvis CT Scan in Management of Patients with Fever of Unknown Origin, Inflammation of Unknown Origin or Episodic Fever of Unknown Origin: A Comparative Multicentre Prospective Study. J Clin Med. 2022 Jan 13;11(2):386. doi: 10.3390/jcm11020386. PMID 35054081

+Investigators

  • Kim LY, MD, Principal investigator, University Hospital, Limoges